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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Executive Summary
Biosimilars are becoming crucial features of
governments’ plans to reduce healthcare
expenditures and increase foreign investment.
Various factors, including financial austerity
measures due to increasing budget deficits and
debt, slowed economic growth in countries such as
the US, an increasing aging population and an
associated increase in the demand for healthcare
in other countries like Japan, are some of the key
drivers of initiatives to encourage the adoption of
biosimilars.
Furthermore, the recent intensification of efforts to
establish frameworks under which biosimilars can
be effectively regulated, by various regulatory
bodies including the US Food Drug and
Administration (FDA), point to a future influx of
biosimilars into significantly untapped markets, as
companies continue to actively position themselves
strategically. Interestingly, pharmaceutical and
biotech companies are not the only ones getting
into the biosimilars business, but also Contract
Manufacturing Organizations (CMOs) such as
Lonza and Celltrion, Contract Research
Organizations (CROs) like Quintiles and Paraxel,
and multi-industry conglomerates such as
Samsung and LG – all companies that fancy a
significant payday from being involved in the
development and sale of biosimilars.
Although biosimilars will deliver some healthcare
cost savings, the discount percentages that were
previously expected have been significantly
reduced. Currently, biosimilars are expected to be
marketed at between 70% and 80% of the cost of
the branded biologic, thereby delivering only a
20%–30% reduction in cost. For instance,
Celltrion’s recently approved Remsima – a
biosimilar to Merck’s Remicade (infliximab) – is
expected to sell for 70% of the price of Remicade
in South Korea. This is in sharp contrast to generic
small-molecule drugs, some of which sell for up to
only 10% of the price of the innovator drug.
However, the expensive nature of biologics, some
of which sell for as much as hundreds of
thousands of dollars for a year’s treatment, makes
even a 20% price reduction quite significant. In
fact, it is estimated that enabling generic options
on just the top 12 categories of biologic treatments
with expired patents would save the US $67–$108
billion over the first 10 years, and $236–$378
billion over 20 years – an average of about $31
billion a year (Shapiro, 2008). This would
significantly aid the government’s efforts to
stabilize the economy and reduce its budget deficit.
Branded Biologics Sales Will Grow through 2017
The growing dependence on biologics to provide
significant benefits in the effective treatment of
chronic diseases such as rheumatoid arthritis,
psoriasis, cancer, Crohn’s Disease and similar
conditions has resulted in the continued increase in
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Executive Summary
sales, generating over $162 billion in 2013 alone.
This trend is expected to continue in the short
term, growing by a Compound Annual Growth Rate
(CAGR) of about 8.3% to reach over $262 billion
by 2019. Afterwards, patent expirations and the
existence of clearer regulatory frameworks for
biosimilars will result in an upsurge of biosimilars in
key biologics markets such as the US, having an
adverse effect on global branded biologic sales.
Furthermore, the uptake of biosimilars is also
expected to increase in other markets outside the
US as physicians and other stakeholders get more
comfortable with their substitution – capturing
market share from branded biologics.
The figure below shows the historical sales of
branded biologics from 2009–2013 and the
forecast to 2019.
Historical Sales of Branded Biologics, 2008–2013 and Forecast to 2019
$93.2 $101.3
$122.8 $137.9
$149.9 $162.6
$175.4 $191.3
$207.0 $224.3
$243.0 $262.5
0
50
100
150
200
250
300
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Bra
nded
Bio
logi
cs S
ales
($bn
)
YearForecastActual
Source: GlobalData, Pharma eTrack [Accessed Apr 17, 2014].
Industry Challenges Result in Caution by Potential Entrants and Current Players
The biosimilars business is not for the faint-
hearted, as various challenges are currently facing
the development and commercialization of
biosimilars. One of these is the uncertainty
regarding the regulatory and legislative structures
available for the review, regulation, and
substitution of biosimilars in certain markets,
particularly the US. Furthermore, the development
of biosimilars involves greater investment than is
required for the development of chemical-based
generics. Biosimilars potentially pose a greater risk
to patient safety than chemical-based generics,
primarily due to issues regarding immunogenicity.
Therefore, they are currently required to undergo
non-clinical, clinical, and post-marketing
surveillance – the same requirements for obtaining
approval for novel biologics. In addition to
potentially resulting in increased review times, the
need for other capital-intensive steps like clinical
testing, as well as the complex manufacturing
processes required, significantly increases the
financial muscle needed to participate in biosimilar
development.
Furthermore, companies currently active in the
field of biologics are establishing various barriers,
including patents protecting their manufacturing
techniques, to prevent or at least slow the entry of
biosimilars into the market. Indeed, companies
such as Amgen, Genentech (now part of Roche),
Pfizer, J&J, and AbbVie are not ready to surrender
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Executive Summary
market share, bearing in mind the substantial sales
being generated by blockbuster drugs such as
Humira (adalimumab), Rituxan (rituximab), Enbrel
(etanercept), Herceptin (trastuzumab), and
Remicade (infliximab). In June 2011, Merck
licensed the biosimilar etanercept from Hanwha
Biologics in a deal worth about $720m over 12
years. However, Amgen’s announcement of a new
Enbrel patent in the US in November 2011 forced
Merck to halt the development of the Enbrel
biosimilar. Similarly, AbbVie has stated that it
intends to aggressively defend about 200 patents
on Humira to prevent the approval of biosimilar
versions, noting that competitors will experience a
difficult time trying to enter into the market.
Consequently, many potential entrants are
exercising caution in advancing their biosimilars
programs. In October 2012, Teva halted Phase III
clinical trials of a biosimilar to Roche’s Rituxan
(rituximab), while Samsung also stopped its
studies on the same drug. Roche does not
anticipate that a rituximab biosimilar will appear on
the market before 2016, three years later than its
initial expectation of 2013 – when Rituxan’s
patents expire in Europe – adding that the
timelines for biosimilars are “moving out.”
Deals Emerging as a Vital Means of Entry into Biosimilars
The noteworthy challenges and risks associated
with the development of biosimilars, particularly in
the current regulatory and economic climate, has
led many companies to embrace strategic deals as
a way to enter and/or strengthen their presence in
the global biosimilars industry. Most of these deals
are collaborations and licensing agreements
targeted at enabling companies to pool their
resources and capabilities, share the risks
involved, and consequently, to improve their
chances of success.
Trends in Deals in Biosimilars Industry, 2007–2013
6
3
8
17
24
20
28
$28.7 $42.9 $45.9$415.0
$1,190.4
$7,498.8
$1,523.3
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000
0
5
10
15
20
25
30
2007 2008 2009 2010 2011 2012 2013Va
lue
of D
eals
($m
)
Num
ber o
f Dea
ls
Number of Deals Value of Deals ($m)
Source: GlobalData, Pharma eTrack [Accessed May 13, 2013].
Despite the company’s past unsuccessful attempts
to develop biosimilars, Merck expanded its existing
joint venture (JV) agreement with Samsung
Bioepis – itself a JV formed by Samsung and
Biogen Idec – in February 2014 to include an
agreement to develop, manufacture and
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Executive Summary
commercialize MK-1293, an insulin glargine
candidate for the treatment of patients with Type 1
and Type 2 diabetes. In addition, on September 3,
2013, Baxter International and Coherus
Biosciences announced an exclusive collaboration
to develop and commercialize an etanercept
biosimilar for marketing in Europe, Canada, Brazil
and certain other markets. Pfenex also signed a
partnership agreement with Strides Arcolab’s Agila
Biotech unit – acquired by Mylan in February 2013
– in a deal that seems to be focused on tapping
into the significantly untapped South Asian and
South-East Asian biosimilars markets. Other deals
include Viropro and Oncobiologics’ partnership to
manufacture six monoclonal antibodies (mAbs)
that are being developed by Oncobiologics, and
Dr. Reddy’s Laboratories’ agreement with Merck
Serono to co-develop a portfolio of biosimilar
compounds in oncology.
US Biosimilars Regulatory Framework Gradually Evolves
In February 2012, the FDA issued three draft
guidances on biosimilar product development in
the US. This is a big step forward for the market as
the US remains the largest pharmaceuticals
market, including biologics; therefore, being able to
obtain approval to market biosimilars in the US
holds considerable benefit. However, the draft
guidelines have been received with mixed feelings,
particularly among companies seeking to pursue
the development of biosimilars in the US. One the
one hand, the draft guidance emphasizes a “totality
of evidence approach” through the use of analytics
and focused clinical trials demonstrating
biosimilarity and allows for the extrapolation across
indications that share the same mechanism of
action. On the other hand, there is the absence of
interchangeability guidiance and an unclear
biosimilar nomenclature. Juxtoposed to this are the
guidelines put in place by the European Medicines
Agency’s (EMA), which are quite transparent and
include a requirement to provide a full dossier
linking back to the originator of a biologic.
Consequently, there are fears that the FDA’s
guidances may, in fact, slow the entry of
biosimilars into the US market.
Governments Utilize Biosimilars Development to Foster Macroeconomic Growth
Emerging markets, including China, India, Brazil
and Mexico, have developed their own regulatory
pathways to manage the approval of biosimilars.
However, they have generally established lower
barriers to entry in terms of clinical trial
requirements and regulatory control, thereby
enabling domestic companies to easily enter the
market, while also potentially providing a lower-
cost entry point for international players. Some of
these governments are actually entering into deals
to drive the growth of their biosimilars industry. In
April 2011, the Brazilian Ministry of Health
(Ministério da Saúde) entered into an agreement
with PharmaPraxis to manufacture a biosimilar to
Humira.
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Executive Summary
Furthermore, the governments of South-East Asian
countries like South Korea have launched various
initiatives targeted at boosting the biosimilars
market and thereby, sustaining their domestic
industry. For instance, the South Korean
government has been setting up bio-clusters, some
of them matching the quality standards of
advanced economies, to foster biopharmaceutical
manufacturing and establish the country as a
leading biosimilars market.
In February 2011, the South Korean government
pledged to promote the biosimilars industry and
revealed plans to provide financial and institutional
support to the industry as well as aim to capture
22% of the global biosimilars market by 2020. Also,
it anticipates the creation of about 120,000 new
jobs by its biosimilars industry.
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Table of Contents
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
1 Table of Contents
1 Table of Contents ....................................................................................................................... 7
1.1 List of Tables .................................................................................................................... 12
1.2 List of Figures ................................................................................................................... 14
2 Introduction ............................................................................................................................... 15
2.1 Report Scope .................................................................................................................... 15
2.2 Upcoming Related Reports ............................................................................................... 16
2.3 Recently Published Reports .............................................................................................. 17
3 Market Overview ....................................................................................................................... 18
3.1 Biologics: An Expensive Necessity .................................................................................... 18
3.2 Historical Branded Biologic Sales and Forecast ................................................................ 20
3.3 A Trickling Biologics Pipeline ............................................................................................ 22
3.4 Why Biosimilars? .............................................................................................................. 22
3.4.1 Rising Healthcare Expenditures .................................................................................... 23
3.4.2 The Need to Broaden Healthcare Coverage and Drive Macroeconomic Growth ........... 23
3.5 Biosimilars: Not an ‘Easy’ Venture .................................................................................... 23
3.5.1 Complex Manufacturing Processes ............................................................................... 24
3.5.2 Rigorous Regulatory Requirements ............................................................................... 25
3.5.3 No Automatic Substitution ............................................................................................. 26
3.6 Clinical Trials Landscape .................................................................................................. 26
4 Biosimilar Deals Trends ............................................................................................................ 31
4.1 Highlighted Deals .............................................................................................................. 32
4.1.1 Baxter International and Coherus Biosciences Announce Biosimilars Collaboration...... 35
4.1.2 Genor BioPharma and BioCND Form mAb Partnership for International Markets ......... 37
4.1.3 Pfenex Forms JV with Agila Biotech .............................................................................. 38
4.1.4 Viropro and Oncobiologics Sign Emerging Markets Biosimilars Deal ............................ 39
4.1.5 Samsung Bioepis and Merck Expand Biosimilars Development Agreement .................. 41
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
4.2 Additional Deals ................................................................................................................ 44
5 Biosimilars Regulation .............................................................................................................. 45
5.1 Biosimilars: Different Names, Common Themes ............................................................... 45
5.2 WHO’s Guidance on SBPs................................................................................................ 45
6 Biosimilars in the US ................................................................................................................. 47
6.1 Overview ........................................................................................................................... 47
6.2 The US’ Evolving Regulatory Framework for Biosimilars ................................................... 47
6.2.1 Big Pharma’s Adverse Reaction to Section 505(b)(2) .................................................... 48
6.2.2 The Patient Protection and Affordable Care Act ............................................................ 50
6.2.3 Recent Guidances on Biosimilars by the FDA ............................................................... 51
6.3 Mixed Feelings among Stakeholders as US States Embrace Biosimilar Substitution ........ 55
6.4 Key Players and Pipelines................................................................................................. 56
6.4.1 Hospira.......................................................................................................................... 56
6.4.2 Actavis .......................................................................................................................... 60
6.4.3 Pfizer ............................................................................................................................. 62
6.5 Biosimilars in the US: Market Outlook ............................................................................... 64
6.5.1 Efforts to Establish a Regulatory Framework Favors the Development of the Industry .. 64
6.5.2 Increasing Healthcare Expenditures Will Drive Biosimilars Substitution ......................... 65
6.5.3 Large Biotechs and Pharmas Will Aggressively Defend their US Market Share ............ 65
6.5.4 Patent Expirations of Blockbuster Biologics Will Encourage Biosimilar Developers ....... 66
7 Biosimilars in Europe ................................................................................................................ 67
7.1 Overview ........................................................................................................................... 67
7.2 EU Approved Biosimilars .................................................................................................. 67
7.3 Guidelines for Biosimilars Development in the EU ............................................................ 70
7.3.1 Sandoz Triggered the Development of Guidelines for Biosimilars in Europe ................. 70
7.3.2 Applicable Guidance Documents on Biosimilars in Europe............................................ 71
7.3.3 Non-Clinical Data and Clinical Studies .......................................................................... 72
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
7.4 Key Players and Pipelines................................................................................................. 73
7.4.1 Sandoz .......................................................................................................................... 73
7.4.2 Stada Arzneimittel ......................................................................................................... 76
7.4.3 Gedeon Richter ............................................................................................................. 78
7.5 Biosimilars in Europe: Market Outlook .............................................................................. 80
7.5.1 Financial Austerity Measures Will Further Drive the Uptake of Biosimilars .................... 80
7.5.2 Companies Will Use the EU Biosimilars Market as a Springboard into the US Market .. 82
8 Biosimilars in Japan .................................................................................................................. 83
8.1 Overview ........................................................................................................................... 83
8.2 Regulatory Framework ...................................................................................................... 83
8.2.1 Organizational Structure ................................................................................................ 83
8.2.2 Biosimilars Review Process .......................................................................................... 84
8.2.3 Regulatory Guidelines ................................................................................................... 85
8.3 Key Players and Pipelines................................................................................................. 87
8.3.1 Kyowa Hakko Kirin Co. Ltd. ........................................................................................... 87
8.3.2 JCR Pharmaceuticals .................................................................................................... 90
8.4 Biosimilars in Japan: Market Outlook ................................................................................ 92
8.4.1 Cost Containment Measures Will Drive Biosimilars Development ................................. 92
8.4.2 CMOs Will Leverage Existing Capabilities to Enter Biosimilars Space........................... 92
9 Biosimilars in India .................................................................................................................... 93
9.1 Gradual Transition from a Semi-Regulated to a Regulated Market .................................... 93
9.2 Marketed Biosimilars in India ............................................................................................ 93
9.3 Regulatory Framework for Biosimilars in India .................................................................. 97
9.3.1 Guidelines on Similar Biologics, 2012 ......................................................................... 101
9.4 Key Players and Pipelines............................................................................................... 102
9.4.1 Biocon ......................................................................................................................... 102
9.4.2 Dr. Reddy’s Laboratories ............................................................................................. 106
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9.4.3 Ranbaxy Laboratories ................................................................................................. 108
9.4.4 Reliance Life Sciences ................................................................................................ 111
9.4.5 Cipla ............................................................................................................................ 112
9.5 India Biosimilars Market Outlook ..................................................................................... 114
9.5.1 Recent Biosimilar Guidelines Will Not Guarantee Approval by Regulators .................. 114
9.5.2 Expertise in Generics Will Encourage Biosimilars Development .................................. 115
9.5.3 EU-India Free Trade Agreement Could Open Up Access to the European Market ...... 115
10 Biosimilars in South Korea ...................................................................................................... 117
10.1 Overview ......................................................................................................................... 117
10.2 Government Initiatives Aiding the Development of Biosimilars ........................................ 119
10.3 Joint Ventures and Collaborations Enable Leveraging of Capabilities ............................. 120
10.4 Lack of Biologics’ Market Exclusivity Decelerates Time-to-Market .................................. 121
10.5 Regulatory Framework for Biosimilars ............................................................................. 121
10.5.1 Extrapolation of Indications ......................................................................................... 123
10.6 Key Players and Pipelines............................................................................................... 123
10.6.1 Celltrion ....................................................................................................................... 124
10.6.2 Hanwha Chemical ....................................................................................................... 127
10.6.3 Samsung Bioepis ........................................................................................................ 129
10.6.4 LG Life Sciences ......................................................................................................... 129
10.7 Biosimilars in South Korea: Market Outlook .................................................................... 132
10.7.1 Government’s Initiatives Look Poised to Spur the Local Biosimilars Industry .............. 132
10.7.2 Budding Pipeline Signals Boom for the Biosimilars Industry ........................................ 133
11 Biosimilars in China ................................................................................................................ 134
11.1 Overview ......................................................................................................................... 134
11.1.1 Soaring Healthcare Expenditures in China Drive Need for Cheaper Therapeutics ...... 134
11.1.2 Biosimilars and Reimbursement .................................................................................. 135
11.1.3 An Intellectual Property Loophole ................................................................................ 136
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11.2 Regulatory Framework for Biosimilars in China ............................................................... 136
11.3 Key Players and Pipelines............................................................................................... 138
11.3.1 3SBio .......................................................................................................................... 138
11.3.2 Shandong Kexing Bioproducts .................................................................................... 140
11.4 Biosimilars in China: Market Outlook ............................................................................... 141
11.4.1 Ongoing Reform Will Boost Biosimilars Industry .......................................................... 141
11.4.2 Increase in Healthcare Access Bodes Well for Biosimilars in China ............................ 141
11.4.3 Collaborations between Multinationals and Domestic Companies Will Continue ......... 142
12 Case Study: Teva Pharmaceutical Industries .......................................................................... 143
12.1 Business Overview ......................................................................................................... 143
12.2 Biosimilars at Teva .......................................................................................................... 143
12.3 Product Portfolio/Pipeline ................................................................................................ 144
12.4 Company SWOT Analysis ............................................................................................... 145
12.4.1 Strengths ..................................................................................................................... 145
12.4.2 Weaknesses................................................................................................................ 147
12.4.3 Opportunities ............................................................................................................... 147
12.4.4 Threats ........................................................................................................................ 149
13 Strategic Outlook .................................................................................................................... 151
13.1 Patent Expiries Will Continually Fuel Biosimilars Development ....................................... 151
13.2 Flurry of Regulatory and Legislative Activities Bodes Well for Biosimilars ....................... 151
13.3 Extensive Capabilities Needed Will Serve as a Barrier to Entry in the Near to Mid-term . 152
13.4 EU-India FTA Will Significantly Benefit European and Indian Biosimilars Companies ..... 153
13.5 Cost-containment Measures Are Expected to Drive Biosimilars Substitution ................... 154
14 Appendix................................................................................................................................. 156
14.1 Bibliography .................................................................................................................... 156
14.2 Abbreviations .................................................................................................................. 165
14.3 Research Methodology ................................................................................................... 169
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
14.3.1 Coverage .................................................................................................................... 169
14.3.2 Secondary Research ................................................................................................... 169
14.4 About the Author ............................................................................................................. 171
14.4.1 Adam Dion, Industry Analyst ....................................................................................... 171
14.5 Director of Healthcare Industry Dynamics ....................................................................... 171
14.6 Global Head of Healthcare .............................................................................................. 172
14.7 About the Industry Dynamics Team ................................................................................ 172
14.8 About GlobalData ............................................................................................................ 173
14.9 Disclosure Information .................................................................................................... 173
14.10 Disclaimer ....................................................................................................................... 173
1.1 List of Tables
Table 1: Major Biologic Products ............................................................................................................... 19
Table 2: Ongoing Biosimilar Clinical Trials................................................................................................. 27
Table 3: Overview of Biosimilars Deals Analyzed in This Report................................................................ 33
Table 4: Baxter International and Coherus Biosciences Biosimilars Collaboration ...................................... 36
Table 5: Genor BioPharma and BioCND Licensing Deal............................................................................ 37
Table 6: Pfenex’s JV with Agila Biotech ..................................................................................................... 38
Table 7: Viropro and Oncobiologics’ Biosimilars Deal ................................................................................ 40
Table 8: Samsung Bioepis and Merck Sign Biosimilars Development Agreement ...................................... 42
Table 9: Biosimilar Evaluation Requirements – WHO, South Korea, EU, and Japan .................................. 46
Table 10: Hospira: Marketed Biosimilars ..................................................................................................... 58
Table 11: Hospira: Biosimilars Developmental Pipeline ............................................................................... 59
Table 12: Actavis’ Biosimilars Pipeline ........................................................................................................ 62
Table 13: Pfizer’s Biosimilars Pipeline ......................................................................................................... 64
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Table 14: Authorized Biosimilars in the EU .................................................................................................. 69
Table 15: Sandoz: Marketed Biosimilars ..................................................................................................... 74
Table 16: Sandoz: Pipeline of Developmental Biosimilars............................................................................ 75
Table 17: Stada Arzneimittel’s Current Biosimilars Pipeline ......................................................................... 78
Table 18: Gedeon Richter’s Current Biosimilars Pipeline ............................................................................. 80
Table 19: Kyowa Hakko Kirin’s Late-stage Biologics Pipeline ...................................................................... 89
Table 20: JCR Pharmaceuticals’ Product Pipeline ....................................................................................... 91
Table 21: Currently Marketed Biosimilars in India ........................................................................................ 95
Table 22: Guidelines Applicable to the Research, Development and Marketing of Biosimilars in India ....... 102
Table 23: Biocon: Marketed Biologics ....................................................................................................... 105
Table 24: Biocon: Current Developmental Biologics Pipeline ..................................................................... 106
Table 25: Dr. Reddy’s: Marketed Biosimilars ............................................................................................. 108
Table 26: Ranbaxy’s Current Biosimilars Pipeline ..................................................................................... 110
Table 27: Reliance Life Sciences: Marketed Biosimilars ............................................................................ 112
Table 28: Reliance Life Sciences: Pipeline Biosimilars .............................................................................. 112
Table 29: Cipla Combined Annual Manufacturing Capacities ..................................................................... 114
Table 30: Some Biosimilars in Development by South Korean Drug Companies ........................................ 118
Table 31: Deals in the South Korean Biosimilars Industry .......................................................................... 120
Table 32: Celltrion Product Pipeline .......................................................................................................... 125
Table 33: Hanwha Chemical’s Current Product Pipeline ............................................................................ 128
Table 34: LG Life Sciences’ Current Product Pipeline ............................................................................... 132
Table 35: 3SBio’s Clinical Pipeline ............................................................................................................ 140
Table 36: Teva Pharmaceutical Industries: Marketed and Developmental Biosimilars ................................ 145
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REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
1.2 List of Figures
Figure 1: Historical Sales of Branded Biologics, 2008–2013 and Forecast to 2019 ..................................... 21
Figure 2: New Biologics* Approvals by the FDA, 2006–2013 ...................................................................... 22
Figure 3: Groups of Companies Involved in Biosimilars Development ......................................................... 25
Figure 4: Trend in Deals in the Biosimilars Industry, 2007–2013 ................................................................. 32
Figure 5: FDA-Recommended Stepwise Approach for Biosimilars’ Development in the US ......................... 52
Figure 6: Current Guidelines on Biosimilars Regulation in the EU ............................................................... 71
Figure 7: Novartis’ Capabilities being Leveraged by Sandoz ....................................................................... 76
Figure 8: Public Debt and Budget Deficit-to-GDP Ratios in the Eurozone, 2013 .......................................... 81
Figure 9: PMDA’s Current Organizational Chart ......................................................................................... 84
Figure 10: Review Process for Biosimilars in Japan...................................................................................... 85
Figure 11: Indian Regulatory Pathway for Indigenously Manufactured Biologics ........................................... 99
Figure 12: Indian Regulatory Pathway for Imported Biologics ..................................................................... 100
Figure 13: South Korean’s Three-tiered Regulatory System for Biosimilars ................................................. 122
Figure 14: Celltrion Product Pipeline by Therapeutic Area .......................................................................... 126
Figure 15: LG Life Sciences’ R&D Investment, 2009–2013 (Estimated) ...................................................... 131
Figure 16: Total and Government Healthcare Expenditures* in China, 2001–2011 ..................................... 135
Figure 17: Application and Approval Procedure for Pharmaceuticals in China............................................. 137
Figure 18: Teva’s Global Biosimilars Operation: A Recipe for Success ....................................................... 144
Figure 19: Teva Generics Sales in US vs. Rest-of-World (ROW), 2009–2012 ............................................. 149
Figure 20: Teva Pharmaceuticals: SWOT Analysis ..................................................................................... 150
Figure 21: Capabilities Needed for Biosimilars Development ...................................................................... 153
Figure 22: US Healthcare Expenditure and GDP, 2001–2013 ..................................................................... 155
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 15 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Introduction
2 Introduction
2.1 Report Scope
This report is an essential source of information and analysis on the global biosimilars industry.
Using detailed company data, financial analysis, corporate strategy, and market trends analysis,
GlobalData provides an in-depth analysis of the current and future growth drivers of the biosimilars
industry. The report discusses the various regulatory frameworks under which biosimilars are
currently reviewed and approved. Furthermore, it discusses the key factors shaping and driving the
biosimilars business, and provides insights on the competitive landscape and emerging strategies
expected to significantly influence the market positions of companies currently involved in the
development and commercialization of biosimilars.
GlobalData’s PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global
Biosimilars Market report provides strategic analysis of the global biosimilars industry. It discusses
key market trends, regulatory requirements in various markets, recent deals activity and trends, as
well as describes the operations strategy of these companies. Furthermore, it includes a
geographical segmentation of various markets including the EU and US, as well as emerging
markets such as India – providing in-depth analysis of these markets’ regulatory framework, key
domestic players and their biosimilar pipelines, and strategic outlook.
Throughout the report, GlobalData’s analysts provide you with expert insight, expanding on each
strategy and factor discussed, with the aim of providing you with the tools needed for making
informed business decisions.
Key Questions Answered
What are the drivers of the global biosimilars industry?
Who are the top players involved in the development of biosimilars in the developed markets of
Europe and the US, as well as in emerging markets, including India and China?
What are the major barriers to entry into the biosimilars industry?
What specific strategies are companies utilizing to combat some of the challenges currently
facing the development of the global biosimilars industry?
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 16 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Introduction
What is the current state of biosimilars regulation in the EU, US, Japan, India, China, and
South Korea?
Key Benefits
This report will enable you to:
Understand the frameworks under which biosimilars are currently being reviewed and
regulated across various developed and emerging markets
Identify the key domestic players in various biosimilar markets, including South Korea, Japan
and emerging markets such as India and China
Understand the key drivers and trends in the global biosimilars industry
Analyze and track the strategies that companies are using to enter and/or strengthen their
position in the rapidly evolving biosimilars industry, as well as efforts being made by innovator
companies like Amgen to protect their market position
Use this information as an independent source for your due diligence and transaction strategy
Companies covered: Actavis, Amgen, Biocon, Celltrion, Cipla, Dr. Reddy’s, Gedeon Richter,
Hospira, JCR Pharmaceuticals, Kyowa Hakko Kirin, LG Life Sciences, Merck, Oncobiologics,
Pfenex, Pfizer, Ranbaxy, Reliance Life Sciences, Samsung Bioepis, Sandoz, Shandong Kexing
Bioproducts, Stada Arzneimittel, Strides Arcolab, Synthon, Teva, Viropro, and 3SBio.
2.2 Upcoming Related Reports
Report titles are subject to change:
GlobalData (2014). PharmaLeaders: Global Pharmaceutical Market Benchmark Report, July
2014
GlobalData (2014). PharmaLeaders: Contract Manufacturing Organizations Benchmark
Report, TBD
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 17 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
Introduction
2.3 Recently Published Reports
GlobalData (2013). PharmaSphere: Global Deal-making Trends and Operations Strategies in
the CRO Market, September, 2013, GDHC007PSR
GlobalData (2013). PharmaSphere: Pharmaceutical and Healthcare Deal Trends in the Asia-
Pacific, September, 2013, GDHC006PSR
GlobalData (2013). PharmaLeaders: Contract Research Organizations Benchmark Report –
Financial Benchmarking & Competitive Landscape Assessment of Leading CROs, August,
2013, GDHC002PLR
GlobalData (2013). PharmaLeaders: Top 10 Pharmaceutical Companies in India Benchmark
Report – Competitive Analysis of the Leading Players in 2013, July, 2013, GDHC003PLR
Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market 173 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Appendix
REGULATORY FRAMEWORKS AND PRODUCT PIPELINES IN THE GLOBAL BIOSIMILARS MARKET
14.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical R&D. Our integrated business intelligence solutions
include a range of interactive online databases, analytical tools, reports, and forecasts. Our
analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Tokyo, and
Singapore.
14.9 Disclosure Information
GlobalData is a product of GlobalData Ltd, a UK-registered company. GlobalData Ltd has no
current or intended investment banking or corporate finance relationships or operations. The
material presented in this report is provided for information purposes only and is not to be used or
considered as a recommendation to buy, hold, or sell any securities or other financial instruments.
No GlobalData Ltd directors, officers, or employees are on the Board of Directors of a covered
company, and no one at a covered company is on the Board of Directors of GlobalData Ltd.
14.10 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior
permission of the publisher, GlobalData.